Agency Forms Undergoing Paperwork Reduction Act Review, 64050-64052 [2022-22928]
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64050
Federal Register / Vol. 87, No. 203 / Friday, October 21, 2022 / Notices
collection activities to increase research
capacity and improve data quality. The
information collected through this
Generic ICR will not be used to make
generalizable statements about the
population of interest or to inform
public policy; however, methodological
findings from these projects may be
reported. The purpose and use of
projects under this National Health and
Nutrition Examination Survey
(NHANES) Generic Clearance would
include developmental projects
necessary for activities such as testing
new procedures, equipment, technology
and approaches that are going to be
folded into NHANES or other NCHS
programs; designing and testing
examination components or survey
questions; creating new studies
including biomonitoring and clinical
measures; creating new cohorts,
including a pregnancy and/or a birth—
24 month cohort; testing of the cognitive
and interpretive aspects of survey
methodology; feasibility testing of
proposed new components or
modifications to existing components;
testing of human-computer interfaces/
usability; assessing the acceptability of
proposed NHANES components among
materials; and conducting customer
satisfaction assessments.
The types of participants covered by
the NHANES Generic ICR may include
current or past NHANES participants;
family or household members of
NHANES participants; individuals
eligible to be participants in NHANES,
but who did not screen into the actual
survey; convenience samples;
volunteers; subject matter experts or
consultants such as survey
methodologist, academic researchers,
clinicians or other health care providers;
NHANES data or website users;
members of the general public or
individuals abroad who would be part
of a collaborative development project
or projects between NCHS and related
public health agencies in the U.S. and/
or abroad. The type of participant
involved in a given developmental
project would be determined by the
nature of the project. The details of each
project will be included in the specific
GenIC submissions.
CDC requests OMB approval for an
estimated 59,465 annualized burden
hours for this Generic ICR. A three-year
clearance is requested. There is no cost
to respondents other than their time.
likely participants; testing alternative
approaches to existing NHANES
procedures, including activities related
to improving nonresponse; testing the
use of or variations/adjustments in
incentives; testing content of web based
surveys; testing the feasibility of
obtaining bodily fluid specimens (e.g.,
blood, urine, semen, saliva, breastmilk)
and tissue samples (swabs); testing
digital imaging technology and related
procedures (e.g., retinal scan, liver
ultrasound, Dual-energy X-ray
absorptiometry (DEXA), prescription
and over-the-counter dietary
supplements bottles); testing the
feasibility of and procedure/processes
for accessing participant’s medical
records from healthcare settings (e.g.,
hospitals and physician offices); testing
the feasibility and protocols for home
examination measurements; testing
survey materials and procedures to
improve response rates, including
changes to advance materials and
protocols, changes to the incentive
structure, introduction of new and
timely outreach and awareness
procedures including the use of social
media; conducting crossover studies;
creating and testing digital survey
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Individuals or Households .................
Developmental Projects & Focus
Group documents.
Developmental Projects & Focus
Group documents.
24-hour developmental projects .......
35,000
1
90/60
52,500
300
1
90/60
450
200
1
25
5,000
Developmental Projects ...................
Focus Group/Developmental Project
Documents.
1,000
15
1
1
90/60
1
1,500
15
...........................................................
........................
........................
........................
59,465
Volunteers .........................................
Individuals or households, Volunteers, NHANES Participants.
NHANES participants ........................
Subject Matter Experts .....................
Total ...........................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–22930 Filed 10–20–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–23–22ER]
Agency Forms Undergoing Paperwork
Reduction Act Review
jspears on DSK121TN23PROD with NOTICES
Number of
responses per
respondent
Type of respondents
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Formative
Respirator and Protective Clothing
Laboratory Testing’’ to the Office of
Management and Budget (OMB) for
VerDate Sep<11>2014
19:08 Oct 20, 2022
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Fmt 4703
Sfmt 4703
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on May 6,
2022, to obtain comments from the
public and affected agencies. One public
comment was received. This notice
serves to allow an additional 30 days for
public and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
E:\FR\FM\21OCN1.SGM
21OCN1
Federal Register / Vol. 87, No. 203 / Friday, October 21, 2022 / Notices
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
jspears on DSK121TN23PROD with NOTICES
Proposed Project
Formative Respirator and Protective
Clothing Laboratory Testing—NEW—
National Institute for Occupational
Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), National Institute for
Occupational Safety and Health
(NIOSH), is requesting approval of a
New Generic Information Collection
Request (ICR) for a period of three years
under the project titled ‘‘Formative
Respirator and Protective Clothing
Laboratory Testing.’’ The National
Personal Protective Technology
Laboratory (NPPTL) is a division of the
NIOSH which operates within the CDC.
NIOSH is the federal institute
specifically dedicated to generating new
knowledge in the field of occupational
safety and health and responsible for
transferring that knowledge into
practice for the betterment of workers.
VerDate Sep<11>2014
19:08 Oct 20, 2022
Jkt 259001
NPPTL was established in 2001, at the
request of Congress, with the mission of
preventing disease, injury, and death for
the millions of working men and
women relying on personal protective
technology (PPT). PPT plays an
important role in keeping many workers
within various industries safe while
performing their professional duties. To
achieve the Laboratory’s mission,
NPPTL conducts scientific research,
develops guidance and authoritative
recommendations, disseminates
information, and responds to requests
for workplace health hazard
evaluations. The development of NPPTL
filled a need for improved personal
protective equipment (PPE) and focused
research into PPT.
Respiratory protection, a specific type
of PPE commonly tested by NPPTL, is
the cornerstone of NPPTL’s efforts. One
of the primary responsibilities of the
Laboratory is to test and approve
respirators used in U.S. occupational
settings. This function ensures a
standard level of quality and filtration
efficiency for all respirators used within
a U.S. workplace setting. The NPPTL
Respirator Approval Program exists to
increase the level of worker protection
from airborne particulates, chemicals,
and vapors. In addition to respirators,
NPPTL conducts research on other types
of PPE, including chemical-resistant
clothing, hearing protection, gloves, eye
and face protective devices, hard hats,
sensors to detect hazardous substances,
and communication devices used for
safety deployment of emergency
workers. NPPTL PPE research examines
exposure to inhalation hazards, dermal
hazards, and any other hazardous
environmental threats within an
occupational setting.
PPE performance requirements and
test methods are specified within: (1)
federal regulations by NIOSH, Food and
Drug Administration (FDA), and the
Mine Safety and Health Administration
(MSHA); and (2) voluntary consensus
standards published by organizations
such as the American National
Standards Institute (ANSI), American
Society for Testing and Materials
(ASTM) International, and International
Organization for Standardization (ISO).
Thus, the information collected from
human subjects in a laboratory setting
are generally consistent across NPPTL
studies with only the boundary
conditions changing (e.g.,
environmental conditions such as heat
or humidity, human subject activity
such as simulated surgery or climbing a
ladder, distance between two subjects
communicating by spoken word,
various PPE use durations, or the use of
novel PPE designs). Considering these
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64051
consistent data collection methods
employed with only changes in
boundary conditions specified to a
specific industry or standard, NPPTL
requests a Generic ICR package for
laboratory-collected information for
testing respirators and protective
clothing.
The resulting data will benefit the
federal government in that the
performance standards and test methods
supported will directly aid in ensuring
the adequate protection via PPE of
workers across a variety of industry
sectors. Furthermore, the continued
research in these methods will ensure
the performance standards and test
methods are up to date with an everevolving workplace safety climate, as
well as technological advancements in
PPE. Through this data collection, the
federal government will ultimately be
able to efficiently react to the PPE
protection needs of workers across the
country thereby fulfilling CDC/NIOSH’s
mission.
The methods used to collect the
information from human participants
will include health screenings,
demographic information collection
instruments, psychometrically
supported surveys of user experience
and perception of PPE, direct
physiological measurements of response
to PPE, biological measures of
physiological responses, anthropometric
measures of body size and shape,
measures of PPE fit, and measures of the
body’s movement through space
(biomechanics). The respondent
universe for the proposed data
collection will be recruited from the
general population but their
demographic characteristics are
expected to be reflective of the full
spectrum of the U.S. workforce and
from industries that rely heavily on PPE
to protect workers (e.g., healthcare and
social assistance, public safety and
emergency response, and agriculture).
Because the U.S. worker population in
some cases includes children down to
the age of eight years in certain
industries such as agriculture, it is
expected that studies included in this
data collection may also include
children. Because respondents will be
recruited via a variety of different
avenues (email, flyers, advertisements,
etc.), it is expected that the respondent
pool will vary in gender, age, race/
ethnicity, persons residing in rural and/
or urban locations, and/or in specific
regions or health jurisdictions.
Additionally, pregnant women may also
be a focus of these data collection efforts
as pregnant women are regular users of
PPE which must be considered due to
E:\FR\FM\21OCN1.SGM
21OCN1
64052
Federal Register / Vol. 87, No. 203 / Friday, October 21, 2022 / Notices
specific needs related to changes in
body shape and size.
CDC estimates that up to 1,750
individuals could be burdened per year
with an estimated annualized burden of
15,591 hours. There is no cost to
respondents other than their time to
participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Members of the general public .......................
Informed Consent ...........................................
Health Screening Questionnaire: Standardized form w/decision logic allowing some
questions to be omitted.
Demographics Questionnaire: Standardized
form w/decision logic allowing some questions to be omitted, W–9 Tax Form, etc.
Job-related Data: Occupational tasks, postures used, duration of exposure, etc.
Physiological Measurements: Chest-worn
heart rate monitor strap, COSMED Kb5,
SQ2020–1F8 temperature logger, TOSCA
500 pulse oximeter, koken breathing
waveform recording mask, etc.
Biological Measurements: Cortisol (stress)
levels, pregnancy tests, hydration status,
lipids, inflammatory markers, heat shock
proteins, etc.
Anthropometric Measurements: Calipers/digital measuring of facial and body dimensions.
Respirator Fit Measurements: Filter cassettes with air pumps,fit-testing equipment,
QLFT/sodium saccharin solution etc.
Self-Perception Data: Level of exertion, perceived comfort level, heat sensation, fatigue, etc.
Biomechanics Measurements: Force plate,
stopwatch, accelerometers, etc.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–22928 Filed 10–20–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10260]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice; partial withdrawal.
AGENCY:
jspears on DSK121TN23PROD with NOTICES
Number of
respondents
Type of respondents
On Wednesday, October 5,
2022, the Centers for Medicare &
Medicaid Services (CMS) published a
notice document entitled, ‘‘Agency
Information Collection Activities:
Proposed Collection; Comment
Request’’. That notice invited public
SUMMARY:
VerDate Sep<11>2014
19:08 Oct 20, 2022
Jkt 259001
comments on two separate information
collection requests, under Document
Identifiers: CMS–10260 and CMS–
10142. Through the publication of this
document, we are withdrawing the
portion of the notice requesting public
comment on the information collection
request titled, ’’ Medicare Advantage
and Prescription Drug Program: Final
Marketing Provisions.’’ Form number:
CMS–10260 (OMB control number:
0938–1051).
The original comment period for
the document that published on October
5, 2022, remains in effect and ends
December 5, 2022.
DATES:
In FR
document, 2022–21657, published on
October 5, 2022 (87 FR 60403), we are
withdrawing item 1 ‘‘Medicare
Advantage and Prescription Drug
Program: Final Marketing Provisions in
42 CFR 422.111(a)(3) and 423.128(a)(3)’’
which begins on page 60404. The notice
will be republished at a later date,
thereby allowing the public to have a
full 60-day comment period.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
970
970
1
6
30/60
1
970
1
30/60
970
1
15/60
200
6
1.5
100
6
15/60
750
1
15/60
225
100
15/60
500
6
15/60
30
3
30/60
Dated: October 17, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–22844 Filed 10–20–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10407 and
CMS–R–244]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
SUMMARY:
E:\FR\FM\21OCN1.SGM
21OCN1
Agencies
[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Notices]
[Pages 64050-64052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22928]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-23-22ER]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Formative Respirator and Protective
Clothing Laboratory Testing'' to the Office of Management and Budget
(OMB) for review and approval. CDC previously published a ``Proposed
Data Collection Submitted for Public Comment and Recommendations''
notice on May 6, 2022, to obtain comments from the public and affected
agencies. One public comment was received. This notice serves to allow
an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including
[[Page 64051]]
whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
Formative Respirator and Protective Clothing Laboratory Testing--
NEW--National Institute for Occupational Safety and Health (NIOSH),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC), National
Institute for Occupational Safety and Health (NIOSH), is requesting
approval of a New Generic Information Collection Request (ICR) for a
period of three years under the project titled ``Formative Respirator
and Protective Clothing Laboratory Testing.'' The National Personal
Protective Technology Laboratory (NPPTL) is a division of the NIOSH
which operates within the CDC. NIOSH is the federal institute
specifically dedicated to generating new knowledge in the field of
occupational safety and health and responsible for transferring that
knowledge into practice for the betterment of workers.
NPPTL was established in 2001, at the request of Congress, with the
mission of preventing disease, injury, and death for the millions of
working men and women relying on personal protective technology (PPT).
PPT plays an important role in keeping many workers within various
industries safe while performing their professional duties. To achieve
the Laboratory's mission, NPPTL conducts scientific research, develops
guidance and authoritative recommendations, disseminates information,
and responds to requests for workplace health hazard evaluations. The
development of NPPTL filled a need for improved personal protective
equipment (PPE) and focused research into PPT.
Respiratory protection, a specific type of PPE commonly tested by
NPPTL, is the cornerstone of NPPTL's efforts. One of the primary
responsibilities of the Laboratory is to test and approve respirators
used in U.S. occupational settings. This function ensures a standard
level of quality and filtration efficiency for all respirators used
within a U.S. workplace setting. The NPPTL Respirator Approval Program
exists to increase the level of worker protection from airborne
particulates, chemicals, and vapors. In addition to respirators, NPPTL
conducts research on other types of PPE, including chemical-resistant
clothing, hearing protection, gloves, eye and face protective devices,
hard hats, sensors to detect hazardous substances, and communication
devices used for safety deployment of emergency workers. NPPTL PPE
research examines exposure to inhalation hazards, dermal hazards, and
any other hazardous environmental threats within an occupational
setting.
PPE performance requirements and test methods are specified within:
(1) federal regulations by NIOSH, Food and Drug Administration (FDA),
and the Mine Safety and Health Administration (MSHA); and (2) voluntary
consensus standards published by organizations such as the American
National Standards Institute (ANSI), American Society for Testing and
Materials (ASTM) International, and International Organization for
Standardization (ISO). Thus, the information collected from human
subjects in a laboratory setting are generally consistent across NPPTL
studies with only the boundary conditions changing (e.g., environmental
conditions such as heat or humidity, human subject activity such as
simulated surgery or climbing a ladder, distance between two subjects
communicating by spoken word, various PPE use durations, or the use of
novel PPE designs). Considering these consistent data collection
methods employed with only changes in boundary conditions specified to
a specific industry or standard, NPPTL requests a Generic ICR package
for laboratory-collected information for testing respirators and
protective clothing.
The resulting data will benefit the federal government in that the
performance standards and test methods supported will directly aid in
ensuring the adequate protection via PPE of workers across a variety of
industry sectors. Furthermore, the continued research in these methods
will ensure the performance standards and test methods are up to date
with an ever-evolving workplace safety climate, as well as
technological advancements in PPE. Through this data collection, the
federal government will ultimately be able to efficiently react to the
PPE protection needs of workers across the country thereby fulfilling
CDC/NIOSH's mission.
The methods used to collect the information from human participants
will include health screenings, demographic information collection
instruments, psychometrically supported surveys of user experience and
perception of PPE, direct physiological measurements of response to
PPE, biological measures of physiological responses, anthropometric
measures of body size and shape, measures of PPE fit, and measures of
the body's movement through space (biomechanics). The respondent
universe for the proposed data collection will be recruited from the
general population but their demographic characteristics are expected
to be reflective of the full spectrum of the U.S. workforce and from
industries that rely heavily on PPE to protect workers (e.g.,
healthcare and social assistance, public safety and emergency response,
and agriculture). Because the U.S. worker population in some cases
includes children down to the age of eight years in certain industries
such as agriculture, it is expected that studies included in this data
collection may also include children. Because respondents will be
recruited via a variety of different avenues (email, flyers,
advertisements, etc.), it is expected that the respondent pool will
vary in gender, age, race/ethnicity, persons residing in rural and/or
urban locations, and/or in specific regions or health jurisdictions.
Additionally, pregnant women may also be a focus of these data
collection efforts as pregnant women are regular users of PPE which
must be considered due to
[[Page 64052]]
specific needs related to changes in body shape and size.
CDC estimates that up to 1,750 individuals could be burdened per
year with an estimated annualized burden of 15,591 hours. There is no
cost to respondents other than their time to participate.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Members of the general public...... Informed Consent........... 970 1 30/60
Health Screening 970 6 1
Questionnaire:
Standardized form w/
decision logic allowing
some questions to be
omitted.
Demographics Questionnaire: 970 1 30/60
Standardized form w/
decision logic allowing
some questions to be
omitted, W-9 Tax Form, etc.
Job-related Data: 970 1 15/60
Occupational tasks,
postures used, duration of
exposure, etc.
Physiological Measurements: 200 6 1.5
Chest-worn heart rate
monitor strap, COSMED Kb5,
SQ2020-1F8 temperature
logger, TOSCA 500 pulse
oximeter, koken breathing
waveform recording mask,
etc.
Biological Measurements: 100 6 15/60
Cortisol (stress) levels,
pregnancy tests, hydration
status, lipids,
inflammatory markers, heat
shock proteins, etc.
Anthropometric 750 1 15/60
Measurements: Calipers/
digital measuring of
facial and body dimensions.
Respirator Fit 225 100 15/60
Measurements: Filter
cassettes with air
pumps,fit-testing
equipment, QLFT/sodium
saccharin solution etc.
Self-Perception Data: Level 500 6 15/60
of exertion, perceived
comfort level, heat
sensation, fatigue, etc.
Biomechanics Measurements: 30 3 30/60
Force plate, stopwatch,
accelerometers, etc.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-22928 Filed 10-20-22; 8:45 am]
BILLING CODE 4163-18-P